Microbiology lab is manual process based lab, less automation than chemistry lab, less regulatory guidance for microbiologist so that DI issue is the major concern in Microbiology lab. The sterility test, the bacterial endotoxin test and microbial enumeration test which involves counting microbial colonies are mostly prone to DI issues. Common DI issues in microbiology lab and control strategies are given below:
Microbiological DI Issues
- Discarding failing data, only reporting passing data, using previously generated data.
- Not following test procedures and sampling plans, missing, altered or raw data, re-run the analysis without justification for better result.
- Electronic records changed without an audit trial.
- Delays between preparation of media and sterilization.
- Disinfectant residues on glassware.
- EM study sample is not taken or dropped in to the incubator without expose.
- Colony forming units are miscounted while counting the plates.
- No reconciliation of paper work and the sample.
- A worksheet being ripped and the results re-write onto a second sheet.
- Not documenting activities or failing to document activities at the time performed.
- Confirmation of number of EM plates expected / received, use of Bar codes to reduce transcription errors and to record actual times and dates, locations.
- Ensure Appropriate prepared media reconciliation record.
- Record the incubation details- time; date; who by, plate withdrew details.
- Maintain Incubator temperature monitoring and door open record by using software.
- For qualitative data consider 2nd person check (contemporaneous). For quantitative data consider automated system.
- Ensure microbiologist can see (visual test) the detail which he/she is tasked for interpreting.
- Reviewers assure the veracity of test results and entries in accordance with DI principles.
- Use validated automatic glass washing equipment, Use automatic validated media makers.
- Agar temperatures during pour plate analysis – water baths with temperature records.
- Evaluation of DI issues using standard risk assessment tools such as FMEA and addition of DI requirement into the URS.
- Multi-level password control, user access rights, previous folder locking system and data backups are required to prevent DI.
- Review the all machine generated electronic data by Supervisor or AQA.
- Audit trail of electronic data should confirm the time of test.
- Observe that there is no evidence of discarded partially completed documentation of any kind use of scrap paper, post it notes, writing on transient paper and paper should be pre-numbered and in chronological order.
- Assure that data is recorded and maintained for all preparations, solutions, etc.
- Make it easier to do the right thing, more difficult to do the wrong thing.
Resource Person: Titon Saha